Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentClosed18 and overNCI, OtherNCCTG-N09C6
NCI-2011-02049, CDR0000675520, U10CA037404, N09C6, NCT01156142

Trial Description

Summary

RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy.

PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.

Further Study Information

OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm II on day 2.
  • Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on day 1.

Patients may crossover to arm I on day 2. The primary and secondary objectives are detailed below.

Primary Objective:

Determine whether doxepin oral rinse is effective in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at 5,15, 30, 60, 120 and 240 minutes

Secondary Objectives:

1. Assess the adverse event profile of doxepin rinse using a patient-reported questionnaire at 5, 15, 30, 60, 120 and 240 minutes for domains of unpleasant taste, burning or stinging discomfort, and drowsiness.

2. Compare the incidence of using alternative analgesics before 4 hours, between the doxepin oral rinse and placebo arms.

3. Assess patient preference for continued therapy with oral rinse after initial test rinse or after the cross-over phase.

NOTE: * Patients are instructed to avoid taking medications for mucositis pain 60 minutes before and after study medication.

After completing study therapy, patients have the option to receive doxepin hydrochloride oral rinse every 4 hours as needed during radiotherapy.

Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes after study medication. Patients who choose to continue doxepin hydrochloride oral rinse also complete weekly questionnaires.

Eligibility Criteria

Inclusion Criteria:

1. ≥ 18 years of age

2. Histologic proof of malignancy currently undergoing a course of RT (with or without chemotherapy) to a dose of ≥ 5000 cGy using 1.60 to 2.20 Gy per fraction. Note: At least one third of the oral cavity mucosa must be included in the radiation therapy fields.

3. ≥ 4 oral pain felt to be related to mucositis for which the patient wants relief as measured by the Numeric Measure of Oral Pain. Note: An oral exam confirming the presence of mucositis should be performed by the enrolling clinician in addition to patient feedback.

4. Ability to complete questionnaire(s) independently or with assistance

5. ECOG Performance Status 0, 1 or 2.

6. Provide informed written consent.

7. Willingness to return to enrolling institution for follow-up.

Exclusion Criteria:

1. Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation

2. Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration

3. Current untreated or unresolved oral candidiasis or oral HSV infection

4. Current untreated narrow angle glaucoma

5. Current untreated urinary retention ≤ 6 weeks prior to registration

6. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

7. Any of the following because this study involves a study agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Robert C. Miller, Study Chair

Trial Sites

U.S.A.

Hawaii
Aiea

Kapiolani Medical Center at Pali Momi

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Honolulu

Cancer Research Center of Hawaii

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Hawaii Medical Center - East

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Kapiolani Medical Center for Women and Children

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

OnCare Hawaii, Incorporated - Kuakini

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

OnCare Hawaii, Incorporated - Lusitana

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Queen's Cancer Institute at Queen's Medical Center

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Straub Clinic and Hospital, Incorporated

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Tripler Army Medical Center

Jeffrey L. Berenberg
Ph: 808-586-2979

Kailua

Castle Medical Center

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Lihue

Kauai Medical Clinic

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Wailuku

Maui Memorial Medical Center

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Pacific Cancer Institute - Maui

William S. Loui
Ph: 808-586-2979
Email: dorothy@crch.hawaii.edu

Illinois
Moline

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Costas L. Constantinou
Ph: 319-363-2690

Indiana
Beech Grove

St. Francis Hospital and Health Centers - Beech Grove Campus

Howard M. Gross
Ph: 317-783-8918

Richmond

Reid Hospital & Health Care Services

Howard M. Gross
Ph: 317-783-8918

Iowa
Mason City

Mercy Cancer Center at Mercy Medical Center - North Iowa

Arvind Y Vemula
Ph: 800-433-3883

Ottumwa

South Iowa Radiation Oncology Center at Ottumwa Regional Health Center

Robert J Behrens
Ph: 888-244-6061
Email: sherrijr@iora.org

Michigan
Flint

Genesys Hurley Cancer Institute

Philip J. Stella
Ph: 734-712-3456

Minnesota
Alexandria

Medini, Eitan MD (UIA Investigator)

Donald J Jurgens
Ph: 877-229-4907
Email: coborncancercenter@centracare.com

Mankato

Immanuel St. Joseph's

Mohmmad J Ranginwala
Ph: 507-385-2929

Saint Cloud

Coborn Cancer Center

Donald J Jurgens
Ph: 877-229-4907
Email: coborncancercenter@centracare.com

Missouri
Bolivar

Central Care Cancer Center at Carrie J. Babb Cancer Center

Robert L Carolla
Ph: 417-269-4520

North Carolina
Rutherfordton

Rutherford Hospital

James Dewitt Bearden
Ph: 800-486-5941

North Dakota
Bismarck

Bismarck Cancer Center

Edward J. Wos
Ph: 701-323-5760
Email: tfischer@mohs.org

Ohio
Dayton

CCOP - Dayton

Howard M. Gross
Ph: 317-783-8918

David L. Rike Cancer Center at Miami Valley Hospital

Howard M. Gross
Ph: 317-783-8918

Good Samaritan Hospital

Howard M. Gross
Ph: 317-783-8918

Grandview Hospital

Howard M. Gross
Ph: 317-783-8918

Samaritan North Cancer Care Center

Howard M. Gross
Ph: 317-783-8918

Findlay

Blanchard Valley Regional Cancer Center

Howard M. Gross
Ph: 317-783-8918

Franklin

Atrium Medical Center

Howard M. Gross
Ph: 317-783-8918

Greenville

Wayne Hospital

Howard M. Gross
Ph: 317-783-8918

Kettering

Charles F. Kettering Memorial Hospital

Howard M. Gross
Ph: 317-783-8918

Troy

UVMC Cancer Care Center at Upper Valley Medical Center

Howard M. Gross
Ph: 317-783-8918

Xenia

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Howard M. Gross
Ph: 317-783-8918

Pennsylvania
Allentown

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Suresh G. Nair
Ph: 610-402-2273

South Carolina
Anderson

AnMed Cancer Center

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Ph: 800-486-5941

Spartanburg

CCOP - Upstate Carolina

James Dewitt Bearden
Ph: 800-486-5941

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

James Dewitt Bearden
Ph: 800-486-5941

South Dakota
Rapid City

Rapid City Regional Hospital

Richard C Tenglin
Ph: 605-716-3982
Email: research@rcrh.org

Sioux Falls

Avera Cancer Institute

Addison R Tolentino
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01156142
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.